Page URL:

Consumer genetics firm 23andMe seeks regulatory approval for disease risk tests

20 August 2012
Appeared in BioNews 669

23andMe, a US-based personal genomics company, has sought regulatory approval from the Food and Drug Administration (FDA) for seven of its genetic tests.

The tests, which 23andMe does not specify, are just some of the 200 or more genetic tests for common diseases, conditions and drug responses offered as part of the company's Personal Genome Service, which currently retails at US$299.

Over the next six months, the company plans to submit another 100 tests for review.

'23andMe is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust', co-founder Anne Wojcicki said in a statement on the company's website.

The application, made under the least stringent of the two types of medical device review, will assess 23andMe's processes for analysing and interpreting genetic test results.

The FDA will check that 23andMe delivers on its medical claims and that it provides the public with access to safe and effective medical devices. The process of review and obtaining clearance is expected to take several months.

Most of the tests approved by the FDA are for a single disease and give a one-off result. Not only does 23andMe test for multiple conditions, the results of genetic testing are continuously updated as more results from genome-wide association studies are published in the scientific literature.

'We are hopeful that the existing regulatory framework is flexible enough to accommodate the dynamic nature of genetic science while protecting individual access', Ashley Gould, Chief Business Officer at 23andMe told Nature.

Until now, 23andMe has avoided government regulation by arguing that it provides an informational, not a medical service.

'It's the next step for us to work with the FDA and actually say, "this is clinically relevant information and consumers should work with their physicians on what to do with it"', Wojcicki told CBC News.

'FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care', she said.

23andMe's genetic testing service, along with other personal genome companies, has already attracted scrutiny from groups including the US Government Accountability Office and the European Academies Science Advisory Council for offering tests that have little clinical value.

However, several accounts are emerging where doctors have been able to use data obtained from companies, such as 23andMe, to identify patients with a higher risk of treatable health problems, such as response to the drug Clopidogrel or colon cancer.

James Evans, professor of genetics and medicine at the University of North Carolina, said much of the information reported by 23andMe is 'relatively useless' and 'in the realm of entertainment', but that in some cases the findings of direct-to-consumer tests can assist doctors to identify certain conditions.

'I think we've now entered an era where these direct-to-consumer offerings are beginning to have real medical relevance, and therefore I am in favour of them being done within some regulatory context', he said. 

Dr Eric Lander, president and director of the Broad Institute of MIT and Harvard, agreed: 'Many consumers are going to want to know this information, and you don't need a hospital to obtain it, so it's important to make sure it's well regulated'.

'I think 23andMe is taking a very forward-leaning step'.

This year has seen 23andMe increase its emphasis on health and disease. Earlier this year it filed a patent for its discovery of a genetic marker in Parkinson's disease. It also recently acquired CureTogether, a website which brings patients together to describe their experiences with disease and treatments.

23andMe personalized DNA test seeks FDA approval
CBS News |  31 July 2012
23andMe Takes First Step Toward FDA Clearance
23andMe (press release) |  30 July 2012
23andMe Takes First Step Toward FDA Clearance
The Spitoon (23andMe blog) |  30 July 2012
Google-Backed 23andMe Asks FDA to Clear DNA Evaluation Service
Bloomberg News |  30 July 2012
Personal-genetics company seeks regulatory approval
Nature News Blog |  31 July 2012
10 April 2017 - by Jamie Rickman 
The US Food and Drug Administration has approved the first genetic test to estimate an individual's risk of disease that can be sold directly to consumers...
23 February 2015 - by Alice Hazelton 
Genetic testing company 23andMe has obtained approval from the US Food and Drug Administration to market a direct-to-consumer genetic test for a rare mutation....
8 December 2014 - by Arit Udoh 
US-based genetic testing company 23andMe has launched its controversial 'personal genome service' in the UK...
9 December 2013 - by Ruth Saunders 
Genetic testing company 23andMe, which last week suspended the sale of its health-related genetic tests, is now facing a class action lawsuit in California over its marketing claims....
2 December 2013 - by Ruth Saunders 
The US Food and Drug Administration has ordered 23andMe to 'immediately discontinue' its Personal Genome Service after failing to undergo proper agency approval for its marketing claims...
9 July 2012 - by Dr Megan Allyse 
When US based, direct-to-consumer genetic testing company 23andMe announced last month that it had obtained a patent on a method for determining predisposition to Parkinson's disease, it highlighted, perhaps inadvertently, a growing area of unresolved tension between clinical, commercial and research interests....
9 July 2012 - by Ruth Saunders 
Two novel gene variants linked to breast size may also also influence the risk of breast cancer, according to a study carried out by US genetics company 23andMe....
6 June 2012 - by Ruth Saunders 
23andMe, a personal genomics company, announced last week that it had been successfully awarded a patent for a gene variant which appears to protect against a high-risk mutation for Parkinson's disease...
2 April 2012 - by Ruth Saunders 
Last week the Parliamentary Office of Science and Technology (POST) released a POST Note - a guide for MPs and other parliamentarians on science and technology issues - on consumer genetic testing...
1 August 2011 - by Rosemary Paxman 
Personal genomics company 23andMe is launching an initiative aiming to shift the balance of participation in both personal genomics and genetic research towards African-Americans...
to add a Comment.

By posting a comment you agree to abide by the BioNews terms and conditions

Syndicate this story - click here to enquire about using this story.